A Pilot Study of Rapamycin in Patients With HIV-Related Kaposi's Sarcoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 7
- 试验地点
- 3
- 主要终点
- Safety and toxicity
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as sirolimus, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sirolimus also may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
PURPOSE: This pilot study is studying sirolimus in treating patients with HIV-related Kaposi's sarcoma.
详细描述
OBJECTIVES:
Primary
- Determine the safety and toxicity of sirolimus in patients with HIV-related Kaposi's sarcoma (KS) receiving protease inhibitor (PI)-based or nonnucleoside reverse transcriptase inhibitor (NNRTI)-based highly active antiretroviral treatment (HAART) regimens.
- Estimate the dose(s) of this drug required to achieve target trough sirolimus plasma concentrations of 5-10 ng/mL in patients receiving PI-based or NNRTI-based HAART regimens.
Secondary
- Evaluate the clinical response of KS in patients treated with this sirolimus.
- Determine the effects of this drug on mTOR-dependent signaling in peripheral blood mononuclear cells (PBMC) and KS tumor biopsies.
- Determine the serum cytokine profiles pre- and post-treatment with this drug.
- Determine the effects of this drug on HIV and KS-associated herpesvirus (KSHV) viral loads.
- Determine the effects of this drug on T-lymphocyte subsets.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Rapamycin
The target rapamycin trough level will be 5-10 ng/mL. The initial dose will be dependent upon the type of HAART regimen.
干预措施: sirolimus (Drug)
结局指标
主要结局
Safety and toxicity
时间窗: All study visits
Dose of sirolimus required to achieve target trough sirolimus plasma concentration
时间窗: Days 8, 15, 21, 29, 43, 57, 85, 113, and every 28 days thereafter
次要结局
- Effect of sirolimus on mTOR-dependent signaling in peripheral blood mononuclear cells (PBMC) and Kaposi's sarcoma (KS) tumor biopsies(baseline, days 1, 15, 29, 57, 113, every 28 days thereafter, study discontinuation)
- Effect of sirolimus on T-lymphocyte subsets(Baseline, Days 29, 113, and at treatment discontinuation)
- Clinical response(Days 1, 29, 57, 85, every 28 days thereafter, at treatment discontinuation, and at study discontinuation.)
- Serum cytokine profile(baseline, days 1, 15, 29, 57, 113, every 28 days thereafter, study discontinuation)
- Effect of sirolimus on HIV and KS-associated herpesvirus viral loads(Days 1, 15, 29, 57, 113, every 28 days thereafter, study discontinuation)